Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00097071
First received: November 17, 2004
Last updated: October 23, 2014
Last verified: October 2014
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Purpose
This trial is conducted in the United States of America (USA). It is demonstrated that intensive insulin therapy resulting in good glycaemic control can reduce or delay the incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin injection (CSII) therapy in the pediatric and adolescent age population. This trial compares the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered by CSII in children and adolescents with type 1 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 1 |
Drug: insulin lispro Drug: insulin aspart |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of Insulin Aspart Versus Insulin Lispro in Insulin Pumps in Children and Adolescents With Type 1 Diabetes |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
MedlinePlus related topics:
Diabetes Type 1
U.S. FDA Resources
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- HbA1c [ Time Frame: After 16 weeks treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Measurements of glycaemic control, safety parameters including frequency of hypoglycaemia, laboratory tests, clinical evaluations and adverse events [ Designated as safety issue: No ]
| Enrollment: | 299 |
| Study Start Date: | October 2004 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 3 Years to 18 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 1 Diabetes
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097071
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00097071
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Locations
| United States, Alabama | |
| Novo Nordisk Clinical Trial Call Center | |
| Mobile, Alabama, United States, 36617 | |
| Novo Nordisk Clinical Trial Call Center | |
| Montgomery, Alabama, United States, 36106 | |
| United States, Arizona | |
| Novo Nordisk Clinical Trial Call Center | |
| Phoenix, Arizona, United States, 85016 | |
| United States, Arkansas | |
| Novo Nordisk Clinical Trial Call Center | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, California | |
| Novo Nordisk Clinical Trial Call Center | |
| Elk Grove, California, United States, 95758 | |
| Novo Nordisk Clinical Trial Call Center | |
| San Diego, California, United States, 92123 | |
| United States, Colorado | |
| Novo Nordisk Clinical Trial Call Center | |
| Denver, Colorado, United States, 80262 | |
| Novo Nordisk Clinical Trial Call Center | |
| Englewood, Colorado, United States, 80110 | |
| United States, Connecticut | |
| Novo Nordisk Clinical Trial Call Center | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| Novo Nordisk Clinical Trial Call Center | |
| Orlando, Florida, United States, 32806-1101 | |
| Novo Nordisk Clinical Trial Call Center | |
| St. Petersburg, Florida, United States, 33701 | |
| Novo Nordisk Clinical Trial Call Center | |
| Tallahassee, Florida, United States, 32308 | |
| United States, Georgia | |
| Novo Nordisk Clinical Trial Call Center | |
| Atlanta, Georgia, United States, 30318 | |
| United States, Idaho | |
| Novo Nordisk Clinical Trial Call Center | |
| Idaho Falls, Idaho, United States, 83404-7542 | |
| United States, Indiana | |
| Novo Nordisk Clinical Trial Call Center | |
| Indianapolis, Indiana, United States, 46202-2879 | |
| United States, Iowa | |
| Novo Nordisk Clinical Trial Call Center | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Novo Nordisk Clinical Trial Call Center | |
| Topeka, Kansas, United States, 66606 | |
| Novo Nordisk Clinical Trial Call Center | |
| Wichita, Kansas, United States, 67226 | |
| United States, Louisiana | |
| Novo Nordisk Clinical Trial Call Center | |
| Baton Rouge, Louisiana, United States, 70808-4311 | |
| United States, Maryland | |
| Novo Nordisk Clinical Trial Call Center | |
| Baltimore, Maryland, United States, 21229 | |
| United States, Massachusetts | |
| Novo Nordisk Clinical Trial Call Center | |
| Boston, Massachusetts, United States, 02115 | |
| Novo Nordisk Clinical Trial Call Center | |
| Boston, Massachusetts, United States, 02215 | |
| Novo Nordisk Clinical Trial Call Center | |
| Springfield, Massachusetts, United States, 01199 | |
| Novo Nordisk Clinical Trial Call Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Minnesota | |
| Novo Nordisk Clinical Trial Call Center | |
| Minneapolis, Minnesota, United States, 55416-2699 | |
| United States, Missouri | |
| Novo Nordisk Clinical Trial Call Center | |
| Kansas City, Missouri, United States, 64108-4619 | |
| United States, Nebraska | |
| Novo Nordisk Clinical Trial Call Center | |
| Omaha, Nebraska, United States, 68114 | |
| Novo Nordisk Clinical Trial Call Center | |
| Omaha, Nebraska, United States, 68198-3020 | |
| United States, New Jersey | |
| Novo Nordisk Clinical Trial Call Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Novo Nordisk Clinical Trial Call Center | |
| Bronx, New York, United States, 10467 | |
| Novo Nordisk Clinical Trial Call Center | |
| Brooklyn, New York, United States, 11219 | |
| Novo Nordisk Clinical Trial Call Center | |
| Buffalo, New York, United States, 14222 | |
| Novo Nordisk Clinical Trial Call Center | |
| Manhasset, New York, United States, 11030 | |
| United States, North Carolina | |
| Novo Nordisk Clinical Trial Call Center | |
| Asheville, North Carolina, United States, 28803 | |
| Novo Nordisk Clinical Trial Call Center | |
| Chapel Hill, North Carolina, United States, 27599-7220 | |
| United States, Ohio | |
| Novo Nordisk Clinical Trial Call Center | |
| Columbus, Ohio, United States, 43203 | |
| United States, Oregon | |
| Novo Nordisk Clinical Trial Call Center | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Novo Nordisk Clinical Trial Call Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Novo Nordisk Clinical Trial Call Center | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| Novo Nordisk Clinical Trial Call Center | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| Novo Nordisk Clinical Trial Call Center | |
| San Antonio, Texas, United States, 78229 | |
| Novo Nordisk Clinical Trial Call Center | |
| San Antonio, Texas, United States, 78284 | |
| United States, West Virginia | |
| Novo Nordisk Clinical Trial Call Center | |
| Charleston, West Virginia, United States, 25302 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00097071 History of Changes |
| Other Study ID Numbers: | ANA-2181 |
| Study First Received: | November 17, 2004 |
| Last Updated: | October 23, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novo Nordisk A/S:
|
Diabetes, Type 1 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
Insulin, Globin Zinc Insulin Insulin Lispro Insulin Aspart Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 26, 2016